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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK ENDOSCOPY HUIBREGTSE TRIPLE LUMEN NEEDLE KNIFE KNS, ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES

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COOK ENDOSCOPY HUIBREGTSE TRIPLE LUMEN NEEDLE KNIFE KNS, ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES Back to Search Results
Catalog Number HPC-3
Device Problem Material Fragmentation (1261)
Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Event Date 08/27/2019
Event Type  Injury  
Manufacturer Narrative
Initial reporter; occupation: unknown. Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation. The report could not be confirmed. The device history record for the lot number said to be involved was reviewed. A discrepancy or anomaly was not observed with the product that was released for distribution. Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation. A definitive cause for the reported observation could not be determined. Needle knife breakage near the distal end can occur if the device is used with excessive cautery settings or if the needle makes contact with the distal end of the endoscope during a cautery application. The instructions for use direct the user: "before using this device, follow recommendations provided by the electrosurgical unit manufacturer to ensure patient safety through proper placement and utilization of patient return electrode. Ensure a proper path from patient return electrode to electrosurgical unit is maintained throughout the procedure. " the instructions for use caution the user: "when applying current, ensure needle knife is completely out of endoscope. Contact of needle knife with endoscope may cause grounding, which can result in patient injury, operator injury, a broken needle knife, and/or damage to endoscope. " needle knife breakage near the distal end can also occur if the product experiences limited movement of the needle knife during electrocautery application. The instructions for use state: "caution: it is essential to move needle knife while applying current. " maintaining the needle knife in one position can result in breakage of the needle knife. Prior to distribution, all huibregtse triple lumen needle knives are subjected to a visual inspection and functional test to ensure device integrity. A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment. Corrective action: a review of the complaint history was conducted. The likelihood of occurrence is considered rare. Corrective action is not warranted at this time based on the quality engineering risk assessment. Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
 
Event Description
During an endoscopic procedure, the physician used a cook huibregtse triple lumen needle knife. The following was found on the maude database, report # (b)(4): "the needle broke off into the papilla and was removed with biopsy forceps. There was no harm to the patient. It is unknown how the procedure was completed. " a section of the device did not remain inside the patient¿s body. The patient required removal of the needle fragment with biopsy forceps due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
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Brand NameHUIBREGTSE TRIPLE LUMEN NEEDLE KNIFE
Type of DeviceKNS, ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES
Manufacturer (Section D)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
Manufacturer (Section G)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
Manufacturer Contact
scottie fariole
4900 bethania station rd
winston-salem, NC 27105
3367440157
MDR Report Key9583492
MDR Text Key189456326
Report Number1037905-2020-00025
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
PMA/PMN Number
K972674
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 12/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/18/2022
Device Catalogue NumberHPC-3
Device Lot NumberW4205332
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/29/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/13/2020 Patient Sequence Number: 1
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